Study to Assess Efficacy and Safety of Zoledronic Acid and the Value of Markers of Bone Resorption in the Prediction of Bone Metastases and Cancer Treatment-induced Bone Loss (CTIBL) in Patients With Prostate Cancer on Hormone Therapy
NCT ID: NCT00172055
Last Updated: 2017-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
218 participants
INTERVENTIONAL
2004-12-31
2009-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ZOL446 (zoledronic acid)
Zoledronic acid
Interventions
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Zoledronic acid
Eligibility Criteria
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Inclusion Criteria
* No evidence of severe osteoporosis
* ECOG performance status 0, 1 or 2
Exclusion Criteria
* Evidence of metabolic bone diseases,
* Treatment with bisphosphonates or calcitonin within the previous year or chronic systemic corticosteroid treatment
* Abnormal kidney or liver function
* Other cancers within the last 5 years
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmeceuticals
Locations
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Novartis Investigative Site
Anderlecht, , Belgium
Novartis Investigative Site
Antwerp, , Belgium
Novartis Investigative Site
Bruges, , Belgium
Novartis Investigative Site
Brussels, , Belgium
Novartis Investigative Site
Charleroi, , Belgium
Novartis Investigative Site
Edegem, , Belgium
Novartis Investigative Site
Ghent, , Belgium
Novaris Investigative Site
Gosselies, , Belgium
Novartis Investigative Site
Kortrijk, , Belgium
Novartis Investigative Site
Leper, , Belgium
Novartis Investigative Site
Leuven, , Belgium
Novaris Investigative Site
Libramont, , Belgium
Novartis Investigative Site
Mont-Godinne, , Belgium
Novartis Investigative Site
Roeselare, , Belgium
Novartis Investigative Site
Tongeren, , Belgium
Novartis Investigative Site
Tournai, , Belgium
Novartis Investigative Site
Turnhout, , Belgium
Novartis Investigative Site
Wilrijk, , Belgium
Novartis Investigative Site
Woluwe-Saint-Lambert, , Belgium
Countries
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Other Identifiers
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CZOL446GBE03
Identifier Type: -
Identifier Source: org_study_id
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